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Clinical Trials in the USA / NCT07528326
Recruiting Not applicable

The TRICURE US IDE Pivotal Study

NCT07528326 · tracked via the Priya Life Science USA tracker
Sponsor
TRiCares
Phase
Not applicable
Started
2026-07-08
Last updated
2026-10-22

Condition(s) studied

Tricuspid Regurgitation (TR)

Investigational drug(s) / intervention(s)

TRiCares Topaz TTVR SystemEdwards EVOQUE TTVR SystemTRiCares Topaz TTVR System

TRiCares Topaz TTVR System: TRiCares Topaz TTVR System

Edwards EVOQUE TTVR System: Edwards EVOQUE TTVR System

TRiCares Topaz TTVR System: TRiCares Topaz TTVR System

Study summary

The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient is ≥ 18 years of age * Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy * Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team Exclusion Criteria: * Patient has a tricuspid device currently in place * Patient has anatomical contraindications * Patient is in need of urgent surgery * Patient has a left ventricular ejection fraction of \< 25% * Patient has life expectancy of \< 1 year

Primary outcome measure(s)

  • Rate of Major Adverse Events (MAE) — 30 days post-procedure
  • Composite Endpoint — 1 year post-procedure
    All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention

Trial sites (1)

FacilityCityRegionStatus
Piedmont Heart Institute Atlanta Georgia Recruiting

More TRiCares trials in the USA

The TRICURE EFS Study Recruiting

Other trials for the same condition

TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (TRINITY-US) Active, not recruiting
A Post-Market Assessment of the Safety and Performance of the TriClip™ System Recruiting
Pivotal Trial to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System (The TRINITY Pivotal Trial) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07528326 on ClinicalTrials.gov ↗ ← All trials in the USA